SOTAX自动溶出仪与普通溶出仪测定西洛他唑片溶出度比较

The vitro dissolution of cilostazol tablets:a comparison between SOTAX auto dissolution tester and common dissolution tester

目的以西洛他唑片为例,利用SOTAX自动溶出仪对溶出度方法作方法学验证。方法采用中国药典西洛他唑的溶出度方法,手动稀释改为自动循环测定(1 mm比色皿)。结果回收率100.1%,重复性RSD为0.4%,回归方程为A=3.7655C-0.0151,r=0.9999,并对自动溶出法和手动溶出法作了比较试验,两者无显著差异。结论自动取样溶出法可以用于西洛他唑片的溶出度检测。

Aim To detect the dissolution rate of cilostazol tablets with SOTAX auto dissolution tester and its methodological validation. Method Dissolution test method of cilostazol tablets in Chinese Pharmacopoeia, auto cycle determination was used instead of manual dilution（ 1 mm colofimetric dish instead of 1 ram）. Results The regression equation was calculated as A = 3. 7655C -0. 0151, r = 0. 9999. The average recovery was 100.1% with RSD of 0.4%. Compared with the manual method,our result is proved to be of the same quality,while the validation of the detection method is effective. Conclusion It can be used for the dissolution determination of cilostazol tablets.